ID

42790

Description

Ropinirole Case Report Form GSK RRL100013 GSK Study ID: 100013 Clinical Study ID: RRL100013 A 12-Week, Double-Blind, Placebo-Controlled, Twice-Daily Dosing Study to Assess the Efficacy and Safety of Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS) Requiring Extended Treatment Coverage

Keywords

Versions (5)
  1. 10/5/17 10/5/17 -
  2. 2/22/18 2/22/18 -
  3. 2/22/18 2/22/18 -
  4. 2/22/18 2/22/18 -
  5. 9/17/21 9/17/21 -
Copyright Holder

gsk

Uploaded on

September 17, 2021

DOI

To request one please log in.

License

Creative Commons BY-NC 3.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

  • Newest
  • Oldest
  • Popular
  • Newest
    • Newest
    • Oldest
    • Popular

No comments

In order to download data models you must be logged in. Please log in or register for free.

Ropinirole Case Report Form GSK RRL100013

English

CONCOMITANT MEDICATIONS

9 forms  
CONCOMITANT MEDICATIONS
Description

CONCOMITANT MEDICATIONS

MONITOR DATA VALIDATION CHECKS
Description

Check that either 'Yes' or 'No' box at the top of the page has been completed. Ensure that the spelling of the Drug Name(s) is correct (use of Trade Names is preferred). Check that either medication start date is completed or 'Taken Prior to Study?' is 'Yes'. It is acceptable for start date to be missing if 'Taken Prior to Study?' is 'Yes'. It is acceptable if 'Taken Prior to Study?' is 'Yes' and a start date is present, as long as the start date is prior to the date of the subject's initial visit Check that either medication stop date is completed or 'Ongoing Medication?' is 'Yes'. It is acceptable for stop date to be missing if 'Ongoing Medication?' is 'Yes'. Ensure that the 'Reason for Medication' is recorded on one of the following pages using the same terms: Current Medical Conditions Non-Serious Adverse Events Serious Adverse Events Form

Data type

text

Alias
UMLS CUI [1]
C1519941
Were any concomitant medications taken by the subject prior to and/or during the study?
Description

If Yes, record each medication on a separate line using Trade Names where possible. If the medication is related to a Non-Serious Adverse Event or Serious Adverse Event, details should be expressed using the same terminology.

Data type

boolean

Alias
UMLS CUI [1]
C2347852
Drug Name
Description

(Trade Name preferred

Data type

text

Alias
UMLS CUI [1]
C0013227
Total Daily Dose
Description

Total Daily Dose

Data type

text

Alias
UMLS CUI [1]
C2348070
units
Description

units

Data type

text

Alias
UMLS CUI [1]
C1519795
Reason for Medication
Description

Reason for Medication

Data type

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0013227
Start Date
Description

Start Date

Data type

text

Alias
UMLS CUI [1]
C0808070
Taken Prior to study?
Description

Taken Prior to study?

Data type

boolean

Alias
UMLS CUI [1]
C2826667
Stop date
Description

Stop date

Data type

date

Ongoing Medication?
Description

Ongoing Medication?

Data type

text

Alias
UMLS CUI [1]
C2826666
Back to the top of the page

Similar models

CONCOMITANT MEDICATIONS

9 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
CONCOMITANT MEDICATIONS
MONITOR DATA VALIDATION CHECKS
Item
MONITOR DATA VALIDATION CHECKS
text
C1519941 (UMLS CUI [1])
Were any concomitant medications taken by the subject prior to and/or during the study?
Item
Were any concomitant medications taken by the subject prior to and/or during the study?
boolean
C2347852 (UMLS CUI [1])
Drug Name
Item
Drug Name
text
C0013227 (UMLS CUI [1])
Total Daily Dose
Item
Total Daily Dose
text
C2348070 (UMLS CUI [1])
units
Item
units
text
C1519795 (UMLS CUI [1])
Reason for Medication
Item
Reason for Medication
text
C0392360 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Start Date
Item
Start Date
text
C0808070 (UMLS CUI [1])
Taken Prior to study?
Item
Taken Prior to study?
boolean
C2826667 (UMLS CUI [1])
Stop date
Item
Stop date
date
Item
Ongoing Medication?
text
C2826666 (UMLS CUI [1])
Ongoing Medication?
Code List
Ongoing Medication?
CL Item
Yes (Y)
CL Item
No (N)
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial